Quality Control Specialist
Hovione is a leading Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.
* We are seeking a Quality Control Specialist to join our team. As a key member of our laboratory, you will be responsible for ensuring the quality of raw materials, intermediate and end products in accordance with regulatory requirements.
The ideal candidate will have a strong background in chemistry or a related field, with experience in GMP regulated QC laboratory environments.
You will work closely with our production team to implement quality control techniques and manage all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
This role requires excellent analytical skills, attention to detail, and effective communication skills. If you have a passion for quality and a drive to succeed, we encourage you to apply.
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Key Responsibilities:
* Define and implement quality control techniques to verify the quality of raw materials, intermediate and end products
* Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines
* FOLLOW THE DAILY PRIORITIES IN ORDER TO ACCURATELY AND PROMPTLY PERFORM THE ALLOCATED SAMPLE ANALYSIS, TO MEET THE REQUIREMENTS OF THE LABORATORY PLAN AND AREA KPIs.
* Take responsibility for all data individually generated and ensure it is in accordance with all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities.
* Maintain all checklists, laboratory records and notebooks in which he/she is involved to an acceptable GMP standard and in accordance with Hovione internal procedures.
* Maintain good hygiene and housekeeping within the laboratory.
* Perform routine calibration and both corrective and preventative maintenance of designated laboratory instruments, requesting any instrument parts and consumables required by the area.
* Comply with the high standards in the QC Laboratories.
* Bring any discrepancies, deviations or non-conformances in testing or work practice to the attention of QC management in accordance with Hovione internal procedures.
* Issue events and support the investigation of OOS/OOT/atypical results, deviations and QC incidents generated in the QC Laboratories.
* Ensure appropriate communication with other internal department in relation to QC work by using the appropriate Hovione processes and their IT platforms.
* Undertake any additional tasks to support the laboratory activities as and when required.
* Seek out additional information when one feels that the available information is not enough.
* Follow all annual performance review requirements, including completion of the self-assessment.
* Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
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Requirements:
* High School diploma (mandatory)
* Qualification in a relevant chemistry, analytical chemistry, chemical engineering, pharmaceutical-related or other science-related field (strong preference)
* Relevant work experience
* Proven practical pharmaceutical or related industry experience in a GMP regulated QC laboratory environment (preferable)
* Experience of GMP practices and HSE standards (preferable)
* Technical understanding of GMP practices, analytical theory and techniques
* Clear and open communication skills (written and verbal)
* Competent (written and verbal) English (preferable for sites where English is not the first language)
* Ability and availability to work in shift patterns, as required by business needs
Benefits:
Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.
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